Long Term Safety, Tolerability and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan, enalapril (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Sponsor GmbH
Overall contact:
Novartis (US) Pharmaceuticals, Phone: 862-778-8300
Summary
The purpose of this extension study is to evaluate in children the long-term (up to 6 months
total) safety and tolerability of valsartan in comparison with enalapril. In addition it will
evaluate proteinuria reduction, renopreservation, and tolerability of valsartan and enalapril
combination vs. enalapril monotherapy alone in patients with chronic kidney disease.
Clinical Details
Official title: A 14 Week Extension to a Randomized, Double-Blind, Multicenter, Parallel-Group, Active-Controlled Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan and Enalapril Combined and Alone in Children 6 to 17 Years of Age With Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Long-term safety and tolerability of valsartan and enalapril alone or in combination in children aged 6-17 years old with hypertension
Secondary outcome: Evaluate the percentage of non-Chronic Kidney Disease (CKD) patients treated with valsartan or enalapril alone with a Mean sitting Systolic Blood Pressure < 95th percentile for gender, age and height from baseline to week 26 (responder).Evaluate the mean seated systolic blood pressure reduction in non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction). Evaluate the mean ambulatory blood pressure reduction for all patients (participating in ABPM) from baseline to week 26 as measured by 24 hour ABPM. Evaluate the percentage of CKD patients treated with valsartan and enalapril combination or enalapril monotherapy achieving urine protein/creatinine ratio (UPCR) reduction by ≥ 25% from week 12 to week 26 Evaluate the percentage of CKD patients on valsartan and enalapril combination vs. enalapril monotherapy who have urine protein/creatinine ratio (UPCR) reduced by ≥ 50% from baseline to week 26
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Successful completion of 12 weeks of double blind treatment in core protocol
CVAL489K2302.
- Patients participating in study CVAL489K2302 who may have discontinued prematurely due
to uncontrolled hypertension defined as; MSSBP >20%, but <25% above the 95th
percentile for age, gender, and height after visit 5, qualifies a patient for entry
into this extension study.
Exclusion Criteria:
- Renal artery stenosis
- Current diagnosis of heart failure (NYHA Class II-IV).
- Second or third degree heart block without a pacemaker.
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
- Clinically significant valvular heart disease.
- Patient that demonstrates clinically significant ECG abnormalities other than those
associated with left ventricular hypertrophy and AV block controlled with a pacemaker
- Previous solid organ transplantation except renal, liver or heart transplantation.
Renal, liver or heart transplant must have occurred at least 6 months prior to
enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months
and deemed clinically stable by the investigator.
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis (US) Pharmaceuticals, Phone: 862-778-8300
Sites in argentina, tbd, Argentina; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Belgium, tbd, Belgium; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Brazil, tbd, Brazil; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Chile, tbd, Chile; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Czech Republic, tbd, Czech Republic; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in France, france, France; Recruiting
Novartis Pharmaceuticials, Phone: 41 61 324 1111
Sites in Germany, tbd, Germany; Recruiting
Novartis Pharmaceuticials, Phone: 41 61 324 1111
Sites in India, tbd, India; Recruiting
Novartis Pharmaceuticals
Sites in Italy, tbd, Italy; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in South Korea, tbd, Korea, Republic of; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Lithuania, tbd, Lithuania; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Poland, tbd, Poland; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Russia, tbd, Russian Federation; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in South Africa, tbd, South Africa; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Sweden, tbd, Sweden; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Switzerland, tbd, Switzerland; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in Turkey, tbd, Turkey; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in United Kingdom, tbd, United Kingdom; Recruiting
Novartis Pharmaceuticals, Phone: 41 61 324 1111
Sites in USA, Little Rock, Alaska, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Sites in USA, Hartford, Connecticut, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Sites in USA, Miami, Florida, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Sites in USA, Hackensack, New Jersey 07936, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
sites in USA, Philadelphia, Pennsylvania, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Sites in USA, Norfolk, Virginia, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Sites in USA, Charleston, West Virginia, United States; Recruiting
Novartis Pharmaceuticals, Phone: 862-778-8300
Additional Information
Starting date: March 2007
Ending date: December 2011
Last updated: June 13, 2008
|
